Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01

FDA recall notice · announced March 21, 2018 · Pfizer

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01

Reason for recall

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot 71330DD EXP. 11/1/2018.
Quantity: 29, 680 vials
Status: Terminated
Products in this recall event:
- Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01 (D-0596-2018)
- Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01 (D-0597-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.